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Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities.

Lobbying Activity

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

15 Jan 2026 · Rare diseases and biotechnology

Meeting with Olga Solomon (Head of Unit Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations and

3 Oct 2025 · The discussion focused on simplifying Annex II to foster innovation while aligning with ICH guidelines, with ideas for legacy products to gradually transition.

Response to EU Life sciences strategy

17 Apr 2025

Biogen welcomes the creation of a European Life Sciences Strategy. As a global biotechnology leader with significant presence and investment in Europe, Biogen is committed to advancing first-in-class treatments and therapies across a range of disease areas, including rare diseases. As such, we support a bold, forward-looking EU approach that strengthens innovation while addressing and reversing Europes relative decline as a destination for life sciences investment. At present, the EU presents regulatory complexity, fragmented markets, and an unpredictable policy environment. Without urgent action, Europe risks falling further behind other major global regions, with fewer clinical trials, slower access to new medicines, and declining investment. The consequences of this would include the erosion of Europes scientific leadership and industrial base, an even greater dependency on third countries, and, ultimately, delayed access to life-saving innovation for European patients. Several ongoing EU policy initiatives may exacerbate this situation. The proposed revision of the EUs general pharmaceutical legislation could reduce intellectual property rights and incentives for innovation, undermining Europes competitiveness, and slowing the research, development, and delivery of new treatments. To restore Europes global competitiveness in life sciences, it is essential to provide the conditions where research-based pharmaceutical companies like Biogen can thrive. This can be achieved by fostering and sustaining innovation through a strong Regulatory Data Protection (RDP) framework and predictable incentives for innovation; by optimizing and simplifying the regulatory system whilst also ensuring sufficient flexibility to accommodate future innovation (e.g., regulatory sandbox); and by improving the clinical trial environment. We note the European Health Data Space (EHDS) has the potential to enhance the EU as a destination for research and clinical trials and contribute to accelerated discoveries, although concerns around the complexity of therapeutic development and safeguarding commercially confidential information remain. Biogen supports the maintenance of enhanced regulatory frameworks and incentives that address the specific challenges associated with the development of, and accessibility to, rare disease treatments. This should be supported by a regulatory environment open to pragmatic innovation which takes a systems-based approach to evidence generation from novel data sources (e.g., patient registries, EHR) and supplemented by an EU Rare Diseases Action Plan to ensure co-ordinated action across different policy areas. To encourage more R&D in rare diseases, orphan incentives should be clear and predictable as well as account for incremental advances that improve patient lives. Finally, it is also key to ensure a comprehensive access ecosystem with harmonised evidence requirements for regulatory and HTA decisions as well as fit-for-purpose HTA methodologies that best capture and reward the value of orphan medicines. The future Life Sciences Strategy should also take a holistic approach towards the industry in Europe, recognising that there are several cross-sectoral pieces of legislation that could impact the industrys ability to operate in Europe. For example, supply chain and environmental regulations must be appropriately proportionate to avoid hindering patient access to medicines. Such is the need for policy coordination that Biogen supports the creation of a European Office for Life Sciences within the European Commission, which would steer and coordinate policymaking guided by a clear vision to make Europe a world-leader in science, innovation and modern manufacturing. The Life Sciences Strategy is an opportunity to course-correct. Europe must act decisively to remain a competitive, attractive location for life sciences innovation. Biogen stands ready to support this effort and improve the lives of European patients.
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and France Assos Santé

16 Feb 2024 · Directive on Medicinal products for human use

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

13 Nov 2023 · Pharmaceutical legislation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and MEDICINES FOR EUROPE

30 Jun 2022 · Generics